Clearance Summary
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA received FDA 510(k) clearance under submission number K120920, sponsored by Hsiner Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2012-07-16.
- Submission: K120920
- Applicant / Sponsor: Hsiner Company
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2012-07-16
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.